A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile conte
| Company | Devices | Share |
|---|---|---|
| Dentsply Professional | 20 | 35% |
| Metrex Research, Llc | 14 | 25% |
| Kentec Medical, Inc. | 5 | 9% |
| Patterson Dental Supply, Inc. | 3 | 5% |
| Dentsply International Inc. | 3 | 5% |
| Misonix, Inc. | 2 | 4% |
| Masimo Corporation | 2 | 4% |
| Graphic Controls Acquisition Corp | 2 | 4% |
| Sterimed Llc | 1 | 2% |
| Air Techniques, Inc. | 1 | 2% |
| Microtek Medical Llc | 1 | 2% |
| Edwards Lifesciences Llc | 1 | 2% |
Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| PEM | Dental barriers and sleeves | 23 |
| EFB | HANDPIECE, AIR-POWERED, DENTAL | 15 |
| MMP | Cover, barrier, protective | 14 |
| KGX | Tape And Bandage, Adhesive | 5 |
| MMP | Cover, Barrier, Protective | 4 |
| LFL | Instrument, Ultrasonic Surgical | 2 |
Use these as the dimensions to specify in a tender line.
57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cable/lead/sensor/probe cover, non-sterile", from 14 companies. The largest labeler is Dentsply Professional with 35% of records.
PEM (Dental barriers and sleeves), EFB (HANDPIECE, AIR-POWERED, DENTAL), MMP (Cover, barrier, protective), KGX (Tape And Bandage, Adhesive)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.